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Real-time Automated Program for IDentification of VT Origin (RAPIDVTPilot)

Primary Purpose

Ventricular Tachycardia, Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
RAPID-VT Software guided ablation
Sponsored by
Amir AbdelWahab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Catheter ablation, ECG imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:

    1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and
    2. One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug:

A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD

Exclusion Criteria:

  • Patients will be excluded from the trial if they:

    1. Are unable or unwilling to provide informed consent.
    2. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization.
    3. Are antiarrhythmic drug-naïve.
    4. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
    5. Have had a prior catheter ablation procedure for VT.
    6. Are in renal failure (Creatinine clearance <15 mL/min)
    7. Have NYHA Functional class IV heart failure or CCS Functional class IV angina.
    8. Have had recent ST elevation myocardial infarction (< 1 month).
    9. Are pregnant or have a systemic illness likely to limit survival to <1 year.

Sites / Locations

  • QE II Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAPID-VT Software guided ablation

Arm Description

The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation

Outcomes

Primary Outcome Measures

Non-inducibility of VT
Lack of any inducible VT at the end of the ablation procedure

Secondary Outcome Measures

Procedure efficacy measure: VT(s) ablated
Number of VTs identified and targeted with ablation
Procedure efficacy measure: Procedure duration
Duration of procedure in minutes
Procedure efficacy measure: VT recurrence
Time to recurrence of VT in months
Procedure safety measure: Acute complications
Incidence of any procedure-related complications
Procedure safety measure: Clinical heart failure worsening
Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT
Procedure safety measure: Mortality and hospitalization for cardiac causes
Death and/or cardiac hospitalization

Full Information

First Posted
April 9, 2018
Last Updated
February 6, 2023
Sponsor
Amir AbdelWahab
Collaborators
Maritime Heart Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03523286
Brief Title
Real-time Automated Program for IDentification of VT Origin
Acronym
RAPIDVTPilot
Official Title
Real-time Automated Program for IDentification of VT Origin - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amir AbdelWahab
Collaborators
Maritime Heart Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
Detailed Description
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration. During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites. Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ischemic Heart Disease
Keywords
Catheter ablation, ECG imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAPID-VT Software guided ablation
Arm Type
Experimental
Arm Description
The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation
Intervention Type
Other
Intervention Name(s)
RAPID-VT Software guided ablation
Intervention Description
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
Primary Outcome Measure Information:
Title
Non-inducibility of VT
Description
Lack of any inducible VT at the end of the ablation procedure
Time Frame
At end of ablation procedure
Secondary Outcome Measure Information:
Title
Procedure efficacy measure: VT(s) ablated
Description
Number of VTs identified and targeted with ablation
Time Frame
At end of procedure
Title
Procedure efficacy measure: Procedure duration
Description
Duration of procedure in minutes
Time Frame
At end of procedure
Title
Procedure efficacy measure: VT recurrence
Description
Time to recurrence of VT in months
Time Frame
During follow up period of 6 months
Title
Procedure safety measure: Acute complications
Description
Incidence of any procedure-related complications
Time Frame
At end of procedure and at 30 days of follow up
Title
Procedure safety measure: Clinical heart failure worsening
Description
Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT
Time Frame
At end of procedure, at 30 days and 6 months of follow up
Title
Procedure safety measure: Mortality and hospitalization for cardiac causes
Description
Death and/or cardiac hospitalization
Time Frame
At 30 days and 6 months of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug: A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD Exclusion Criteria: Patients will be excluded from the trial if they: Are unable or unwilling to provide informed consent. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization. Are antiarrhythmic drug-naïve. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves. Have had a prior catheter ablation procedure for VT. Are in renal failure (Creatinine clearance <15 mL/min) Have NYHA Functional class IV heart failure or CCS Functional class IV angina. Have had recent ST elevation myocardial infarction (< 1 month). Are pregnant or have a systemic illness likely to limit survival to <1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir AbdelWahab
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Real-time Automated Program for IDentification of VT Origin

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